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Completed

NCT Number: NCT04949841

Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials

The purpose of this extension trial is to evaluate the long-term safety of delgocitinib.

Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.

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Key information

Conditions

Chronic Hand Eczema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

LEO Investigational Site, Brussels, Belgium

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About this study

Subject who completed 16 weeks of treatment with delgocitinib cream 20 mg/g or vehicle cream twice daily in trials DELTA 1 or DELTA 2 will be offered to roll-over to this extension trial.

Subjects will be treated with delgocitinib cream 20 mg/g twice daily only if they need it to control their chronic hand eczema. In the periods when the disease is controlled, no treatment will be administered.

Clinic visits every 4 weeks are planned (with the possibility of unscheduled visits) to investigate safety and efficacy of treatment, as well as its effect on patient-reported outcomes (PROs).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have met eligibility criteria at screening and baseline in the parent trial (DELTA 1 or DELTA 2).
  • Participants must have completed the treatment period in the parent trial (to be assessed at baseline visit in this extension trial).
  • Participants must have complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
  • A woman of childbearing potential must use an acceptable method of birth control throughout the trial up until the end-of-treatment/early termination visit.

Exclusion criteria

  • Participants who prematurely discontinued treatment with IMP or initiated rescue medication in the parent trial.
  • Participants who experienced any adverse event (AE) during participation in the parent trial, which precludes further treatment with delgocitinib cream 20 mg/g in the judgement of the investigator.
  • Any medical or psychiatric condition that could put the participant at undue risk by participating in the trial, or which, by the investigator's judgment, makes the participant inappropriate for the trial.

Treatment and study plan

Delgocitinib

Drug

Delgocitinib cream 20 mg/g

Primary outcomes

  1. Number of Treatment-emergent Adverse Events From Baseline up to Week 38

    Time frame: From baseline up to Week 38

    An AE will be considered treatment emergent if it started after the baseline visit

Secondary outcomes

  1. Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36

    Time frame: From baseline up to Week 38

    The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  2. Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.

    Time frame: From baseline up to Week 38

    The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  3. HECSI Score at Each Scheduled Visit From Baseline up to Week 36

    Time frame: From baseline up to Week 38

    The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score).

  4. Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36

    Time frame: From baseline up to Week 38

    The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-75 is defined as at least 75% improvement in HECSI score from parent trial baseline.

  5. Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36

    Time frame: From baseline up to Week 38

    The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-90 is defined as at least 90% improvement in HECSI score from parent trial baseline.

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)

Acronym: DELTA 3

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 2, 2021
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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